Fetal Aortic Valvuloplasty for Hypoplastic Left Heart Syndrome

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Mauro H. Schenone

Disqualifiers: Age, Anesthesia, Preterm labor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to manage hypoplastic left heart syndrome (HLHS), a severe heart condition affecting unborn babies. Researchers compare two approaches: fetal aortic valvuloplasty, performed while the baby is still in the womb, and traditional post-birth surgery. The trial seeks pregnant women between 21 and 29 weeks of gestation with a baby diagnosed with evolving HLHS. Participants should have a dominant heart defect related to the heart's valves and exhibit specific symptoms, such as abnormal blood flow patterns.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve treatment options for future families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that fetal aortic valvuloplasty is safe for managing hypoplastic left heart syndrome?

Research has shown that fetal aortic valvuloplasty is generally well-tolerated. In a study of 71 cases since 2009, the procedure succeeded 94% of the time, indicating it usually goes as planned. The risk of losing the baby before birth was low, at 4%. These findings suggest the procedure is relatively safe for the unborn baby.

Available studies report no major negative effects, indicating that most patients handle the procedure well. However, like any medical procedure, risks are involved. Discuss these with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fetal aortic valvuloplasty for Hypoplastic Left Heart Syndrome (HLHS) because it offers a prenatal intervention that could potentially improve heart function before birth. Current treatments for HLHS typically involve multiple complex surgeries after birth, but fetal aortic valvuloplasty is performed between 21 and 29 weeks of gestation, aiming to address the problem earlier. By intervening during fetal development, this procedure could improve outcomes and reduce the need for more invasive surgeries after birth. This approach represents a shift towards treating congenital heart defects earlier, possibly enhancing survival and heart function for infants affected by HLHS.

What evidence suggests that fetal aortic valvuloplasty might be an effective treatment for hypoplastic left heart syndrome?

Research has shown that fetal aortic valvuloplasty, which participants in this trial may receive, could be a promising treatment for hypoplastic left heart syndrome (HLHS). In a study with 71 patients, doctors successfully performed the procedure in 94% of cases, with only 4% resulting in fetal loss. Additionally, 66% of these cases achieved biventricular circulation, meaning both sides of the heart worked well together. Over an average follow-up of 5.4 years, patients who had successful procedures showed a high survival rate, with 96% avoiding heart-related death at 5 years and 84% at 10 years. These findings suggest that this treatment could improve outcomes for those with HLHS. Meanwhile, the control group in this trial will undergo expectant management with postnatal surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Mauro Schenone, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-45 with a fetus diagnosed with evolving hypoplastic left heart syndrome (HLHS). The mother must be healthy for surgery, between 21 and almost 30 weeks pregnant. Criteria include specific measurements of the fetal heart's structure and function indicating potential for successful treatment.

Inclusion Criteria

I am healthy enough for surgery.

Gestational age between 21 0/7 and 29 6/7 weeks of gestation

My main heart issue is related to the heart valves.

Exclusion Criteria

Cases with all the following criteria: Left ventricle pressure ≤ 47 mmHg, MV dimension Z-score < 0.1, MV inflow time Z-score < -2

I cannot have surgery or anesthesia due to health risks.

Preterm labor or cervical length <20 mm at enrollment or uterine anomaly strongly predisposing to preterm delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fetal aortic valvuloplasty is performed between 21 and 29 weeks gestation to increase the size of the baby's aortic valve

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fetal Aortic Valvuloplasty

Trial Overview The study tests fetal aortic valvuloplasty using specialized catheters like Emerge Monorail, Over-The-Wire PTCA Dilatation Catheter, Trek RX, and Mini Trek RX to manage HLHS in fetuses. It aims to find out if this can improve outcomes by promoting normal left heart development.

How Is the Trial Designed?

Group I: Intervention Group: Fetal Aortic Valvuloplasty Experimental Treatment 3 Interventions

Women diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation.

Group II: Control Group: Expectant Management Active Control 1 Intervention

Women diagnosed with HLHS will undergo expectant management with postnatal surgery.

Who Is Running the Clinical Trial?

Mauro H. Schenone

Lead Sponsor

Trials

2

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7737668/

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left ... Since 2009 (n=71), all outcomes have improved including probability of technical success (94%), fetal demise (4%), and biventricular circulation (66%) (Table 1) ...

2. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.114.009032

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left ... After a median follow-up of 5.4 years, freedom from cardiac death among all BV patients was 96±4% at 5 years and 84±12% at 10 years, which was ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05386173

Effect of Fetal Aortic Valvuloplasty on Outcomes The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05386173

Effect of Fetal Aortic Valvuloplasty on Outcomes Effect of Fetal Aortic Valvuloplasty on Outcomes. a study on Congenital Heart Defects Aortic Stenosis Fetal Cardiac Disorder Hypoplastic Left ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31050019/

Outcomes of hypoplastic left heart syndrome and fetal ... Fetal aortic valvuloplasty was performed successfully in nine cases of eHLHS. Overall postnatal survival was 44% in AoS with fetal aortic valvuloplasty, and one ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.119.006127

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left ... Since 2009 (n=71), all outcomes have improved including probability of technical success (94%), fetal demise (4%), and biventricular circulation ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06342999

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left ... This is called fetal aortic valvuloplasty. A number of studies have shown promising results, including a higher of the baby surviving with both sides of the ...

8. trialx.com trialx.com/clinical-trials/listings/257876/effect-of-fetal-aortic-valvuloplasty-on-outcomes/

Effect of Fetal Aortic Valvuloplasty on Outcomes The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the ...